FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
The FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body's key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm.
ABRE Clinical Study Meets Primary Safety and Effectiveness Endpoints
The ABRE Study is a prospective, interventional, single-arm, multi-center, worldwide study, which included 200 subjects with symptomatic iliofemoral venous outflow obstruction from 24 sites throughout the U.S. and Europe.
Lucence, A*STAR Share Study Data Showing SAFER™ Sample Saliva Collection Kit for COVID-19 Inactivates Collected Virus
SAFER Sample Collection Kit is registered as a Class A medical device with the Health Sciences Authority of Singapore and is an easy-to-use saliva collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week.
INFINITY Angioplasty Balloon Catheter™ Receives 510(k) Clearance
"The INFINITY catheter represents a game changing innovation in percutaneous angioplasty balloon design and utility," states founder and vascular surgeon, John Pigott, MD. "A single SKU to treat lesions from 40mm-250mm in length, is adjustable, to the millimeter, in vivo assuring Precision Angioplasty™, while addressing over 95 percent of real-life clinical cases."
Zavation Medical Products Launches Cortical Screw – Latest Portfolio Addition
The Cortical Screw is the latest addition to Zavation's portfolio. The cortical screw is designed to achieve greater cortical bone purchase with a smaller midline incision when using Cortical Bone Trajectory.